Which companies are listed, and at what stages?
Each source is counted separately. Expand a list to inspect companies, identifiers, dates and sources.
Chemical-drug catalogue
Loaded records: 4 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 2 in the new chemical-registration-classification generic category. Category counts may overlap.
| Marketing authorization holder | Manufacturer | Approval number | Approved | Strength / specification | Catalogue category (source text) | View source |
|---|---|---|---|---|---|---|
| 石家庄科仁医药科技有限公司 | 石家庄科仁医药科技有限公司 | 国药准字H20263993 | 2026/04/14 | 5mg | Not stated by source | CDE |
| 石药集团中诺药业（石家庄）有限公司 | 石药集团中诺药业（石家庄）有限公司 | 国药准字H20253336 | 2025/02/08 | 5mg | 按化学药品新注册分类批准的仿制药 | CDE |
| 丽珠集团丽珠制药厂 | 丽珠集团丽珠制药厂 | 国药准字H20070256 | 2007/12/11 | 5mg | 创新药 | CDE |
| 云鹏医药集团有限公司 | 以岭万洲国际制药有限公司 | 国药准字H20266240 | 2026/10/13 | 5mg | 按化学药品新注册分类批准的仿制药 | CDE |
Distinct full holder names; manufacturers are used only where the holder is unstated. The catalogue covers only part of the chemical-drug market. Categories are counted as recorded, not as a complete market census.
NHSA drug codes
Loaded records: 3 distinct approval numbers and 3 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 石家庄科仁医药科技有限公司 | 国药准字H20263993 | 5mg | 乙 | XA02BCA084A012010183837 | NHSA |
| 石家庄科仁医药科技有限公司 | 国药准字H20263993 | 5mg | 乙 | XA02BCA084A012010283837 | NHSA |
| 石家庄科仁医药科技有限公司 | 国药准字H20263993 | 5mg | 乙 | XA02BCA084A012010383837 | NHSA |
| 石家庄科仁医药科技有限公司 | 国药准字H20263993 | 5mg | 乙 | XA02BCA084A012010483837 | NHSA |
| 石药集团中诺药业(石家庄)有限公司 | 国药准字H20253336 | 5mg | 乙 | XA02BCA084A012010102777 | NHSA |
| 石药集团中诺药业(石家庄)有限公司 | 国药准字H20253336 | 5mg | 乙 | XA02BCA084A012010202777 | NHSA |
| 丽珠集团丽珠制药厂 | 国药准字H20070256 | 5mg | 乙 | XA02BCA084A012010100453 | NHSA |
| 丽珠集团丽珠制药厂 | 国药准字H20070256 | 5mg | 乙 | XA02BCA084A012010200453 | NHSA |
| 丽珠集团丽珠制药厂 | 国药准字H20070256 | 5mg | 乙 | XA02BCA084A012010300453 | NHSA |
| 丽珠集团丽珠制药厂 | 国药准字H20070256 | 5mg | 乙 | XA02BCA084A012010400453 | NHSA |
Approval numbers and companies are deduplicated separately; packaging records remain individually listed. An empty insurance class means it is unstated. NHSA codes supply no approval date and do not establish the outcome of an acceptance number.
Current under-review applications
Loaded records: 26 filings and 26 distinct first applicants.
Generic 25 · Supplement 1
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 山东鲁抗医药集团赛特有限责任公司;吉林四环制药有限公司 | CYHS2602077 | Generic | 2026/08/20 | Not stated by source | CDE |
| 江苏和晨药业有限公司 | CYHS2602103 | Generic | 2026/08/24 | Not stated by source | CDE |
| 海南广升誉制药有限公司;江苏诚康药业有限公司 | CYHS2504371 | Generic | 2025/12/24 | Not stated by source | CDE |
| 江苏永安制药有限公司 | CYHS2601826 | Generic | 2026/07/29 | Not stated by source | CDE |
| 江苏悦兴药业有限公司;山东朗诺制药有限公司 | CYHB2600843 | Supplement | 2026/04/29 | Not stated by source | CDE |
| 江苏飞马药业有限公司 | CYHS2502466 | Generic | 2025/07/11 | Not stated by source | CDE |
| 广东安诺药业股份有限公司 | CYHS2601958 | Generic | 2026/08/10 | Not stated by source | CDE |
| 北京福元医药股份有限公司 | CYHS2601671 | Generic | 2026/07/14 | Not stated by source | CDE |
| 河北龙海药业股份有限公司 | CYHS2601289 | Generic | 2026/06/03 | Not stated by source | CDE |
| 浙江昂利康制药股份有限公司 | CYHS2601203 | Generic | 2026/05/27 | Not stated by source | CDE |
| 山东药石药业有限公司 | CYHS2601030 | Generic | 2026/05/07 | Not stated by source | CDE |
| 湖南欧拉医药科技有限公司;湖南方盛制药股份有限公司 | CYHS2600641 | Generic | 2026/03/11 | Not stated by source | CDE |
| 湖南华纳大药厂股份有限公司 | CYHS2600187 | Generic | 2026/01/16 | Not stated by source | CDE |
| 浙江益汉制药有限公司 | CYHS2600125 | Generic | 2026/01/10 | Not stated by source | CDE |
| 安徽佳和药业有限公司 | CYHS2504460 | Generic | 2025/12/30 | Not stated by source | CDE |
| 哈尔滨松鹤制药有限公司 | CYHS2504377 | Generic | 2025/12/24 | Not stated by source | CDE |
| 中山万汉制药有限公司 | CYHS2504215 | Generic | 2025/12/09 | Not stated by source | CDE |
| 浙江华海制药科技有限公司 | CYHS2504160 | Generic | 2025/12/03 | Not stated by source | CDE |
| 广州市联瑞制药有限公司 | CYHS2503813 | Generic | 2025/10/28 | Not stated by source | CDE |
| 广西科伦制药有限公司;四川科伦药业股份有限公司 | CYHS2503699 | Generic | 2025/10/16 | Not stated by source | CDE |
| 广东君康药业有限公司;瑞华（中山）制药有限公司 | CYHS2502961 | Generic | 2025/08/13 | Not stated by source | CDE |
| 宁波科尔康美诺华药业有限公司;宁波美诺华天康药业有限公司 | CYHS2502430 | Generic | 2025/07/09 | Not stated by source | CDE |
| 山东朗诺制药有限公司 | CYHS2502096 | Generic | 2025/06/12 | Not stated by source | CDE |
| 安徽长江药业有限公司 | CYHS2501377 | Generic | 2025/04/10 | Not stated by source | CDE |
| 浙江高跖医药科技股份有限公司;浙江赛默制药有限公司 | CYHS2501186 | Generic | 2025/03/26 | Not stated by source | CDE |
| 重庆圣华曦药业股份有限公司 | CYHS2500047 | Generic | 2025/01/04 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 13 filings and 11 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 山东鲁抗医药集团赛特有限责任公司;吉林四环制药有限公司 | CYHS2602077 | Generic | 2026/08/20 | Not stated by source | CDE |
| 江苏和晨药业有限公司 | CYHS2602103 | Generic | 2026/08/24 | Not stated by source | CDE |
| 江苏和晨药业有限公司 | CYHS2601265 | Generic | 2026/06/04 | Not stated by source | CDE |
| 江苏永安制药有限公司 | CYHS2601826 | Generic | 2026/07/29 | Not stated by source | CDE |
| 广东安诺药业股份有限公司 | CYHS2601958 | Generic | 2026/08/10 | Not stated by source | CDE |
| 北京福元医药股份有限公司 | CYHS2601671 | Generic | 2026/07/14 | Not stated by source | CDE |
| 广东安诺药业股份有限公司 | CYHS2601261 | Generic | 2026/06/04 | Not stated by source | CDE |
| 河北龙海药业股份有限公司 | CYHS2601289 | Generic | 2026/06/03 | Not stated by source | CDE |
| 浙江昂利康制药股份有限公司 | CYHS2601203 | Generic | 2026/05/27 | Not stated by source | CDE |
| 山东药石药业有限公司 | CYHS2601030 | Generic | 2026/05/07 | Not stated by source | CDE |
| 湖南欧拉医药科技有限公司;湖南方盛制药股份有限公司 | CYHS2600641 | Generic | 2026/03/11 | Not stated by source | CDE |
| 湖南华纳大药厂股份有限公司 | CYHS2600187 | Generic | 2026/01/16 | Not stated by source | CDE |
| 浙江益汉制药有限公司 | CYHS2600125 | Generic | 2026/01/10 | Not stated by source | CDE |
API registrations
Non-component matches: 14 companies with A status and 18 I-status records. Component matches are listed separately and excluded from these counts.
| Name | Company / applicant | Registration number | Status | Name match | Source update date | View source |
|---|---|---|---|---|---|---|
| 艾普拉唑钠 | 连云港贵科药业有限公司 | Y20260000381 | I | Salt-normalized ingredient | 2026/06/03 | CDE |
| 艾普拉唑 | 北京福元医药股份有限公司 | Y20260000360 | I | Exact ingredient | 2026/04/30 | CDE |
| 艾普拉唑钠 | 山东辰龙药业有限公司 | Y20260000104 | I | Salt-normalized ingredient | 2026/02/09 | CDE |
| 艾普拉唑 | 浙江赛默制药有限公司 | Y20250001430 | I | Exact ingredient | 2026/01/05 | CDE |
| 艾普拉唑 | 焦作丽珠合成制药有限公司 | Y20250001162 | I | Exact ingredient | 2025/11/11 | CDE |
| 艾普拉唑 | 福建南方制药股份有限公司 | Y20250001063 | I | Exact ingredient | 2025/10/15 | CDE |
| 艾普拉唑 | 四川科伦药业股份有限公司 | Y20250000807 | I | Exact ingredient | 2025/09/29 | CDE |
| 艾普拉唑 | 新天地药业股份有限公司 | Y20250001026 | I | Exact ingredient | 2025/09/28 | CDE |
| 艾普拉唑 | 江苏诺泰澳赛诺生物制药股份有限公司 | Y20250000996 | I | Exact ingredient | 2025/09/19 | CDE |
| 艾普拉唑 | 湖南华纳大药厂手性药物有限公司 | Y20250000860 | I | Exact ingredient | 2025/09/03 | CDE |
| 艾普拉唑 | 苏州盛达药业有限公司 | Y20250000771 | I | Exact ingredient | 2025/08/12 | CDE |
| 艾普拉唑 | 湖北赛奥生物制药有限公司 | Y20250000710 | I | Exact ingredient | 2025/07/18 | CDE |
| 艾普拉唑 | 重庆莱美隆宇药业有限公司 | Y20250000565 | I | Exact ingredient | 2025/07/14 | CDE |
| 艾普拉唑 | 苏州盛达药业有限公司 | Y20250000404 | I | Exact ingredient | 2025/06/10 | CDE |
| 艾普拉唑 | 浙江美诺华药物化学有限公司 | Y20240000994 | I | Exact ingredient | 2025/06/04 | CDE |
| 艾普拉唑 | 珠海海瑞德制药有限公司 | Y20250000381 | A | Exact ingredient | 2026/09/22 | CDE |
| 艾普拉唑 | 石家庄龙泽制药股份有限公司 | Y20250000339 | I | Exact ingredient | 2025/04/27 | CDE |
| 艾普拉唑 | 山东辰龙药业有限公司 | Y20250000029 | A | Exact ingredient | 2026/08/31 | CDE |
| 艾普拉唑 | 湘北威尔曼制药股份有限公司 | Y20240001539 | A | Exact ingredient | 2026/07/13 | CDE |
| 艾普拉唑钠 | 山东朗诺制药有限公司 | Y20240001344 | I | Salt-normalized ingredient | 2024/12/30 | CDE |
| 艾普拉唑 | 甘肃皓天医药科技有限责任公司 | Y20240001388 | A | Exact ingredient | 2026/07/20 | CDE |
| 艾普拉唑 | 湖南明瑞制药股份有限公司 | Y20240001317 | A | Exact ingredient | 2026/04/21 | CDE |
| 艾普拉唑 | 山东朗诺制药有限公司 | Y20240001265 | A | Exact ingredient | 2026/09/21 | CDE |
| 艾普拉唑 | 连云港贵科药业有限公司 | Y20240001155 | A | Exact ingredient | 2026/05/20 | CDE |
| 艾普拉唑 | 浙江仙琚制药股份有限公司 | Y20240000870 | A | Exact ingredient | 2026/01/05 | CDE |
| 艾普拉唑 | 四川青木制药有限公司 | Y20240000867 | A | Exact ingredient | 2026/01/16 | CDE |
| 艾普拉唑 | 河北安健成益医药科技有限公司 | Y20240000861 | A | Exact ingredient | 2025/12/29 | CDE |
| 艾普拉唑 | 重庆圣华曦药业股份有限公司 | Y20240000700 | I | Exact ingredient | 2024/08/05 | CDE |
| 艾普拉唑 | 成都通德药业有限公司 | Y20240000521 | A | Exact ingredient | 2025/12/29 | CDE |
| 艾普拉唑钠 | 浙江恒康药业股份有限公司 | Y20230001212 | A | Salt-normalized ingredient | 2026/01/21 | CDE |
| 艾普拉唑 | 浙江恒康药业股份有限公司 | Y20230001213 | A | Exact ingredient | 2025/08/06 | CDE |
| 艾普拉唑 | 石药集团欧意药业有限公司 | Y20230000888 | A | Exact ingredient | 2025/02/15 | CDE |
| 艾普拉唑 | 珠海保税区丽珠合成制药有限公司 | Y20190009784 | A | Exact ingredient | 2026/01/13 | CDE |
| 艾普拉唑钠 | 珠海保税区丽珠合成制药有限公司 | Y20170001429 | A | Salt-normalized ingredient | 2023/03/24 | CDE |
A/I are source statuses. Matching uses exact ingredients, salt-normalized names and maintained combination components, without fuzzy matching. A-status companies are deduplicated by the first registered company. Components are excluded from headline counts; the register does not identify the associated formulation.
What changed recently?
Last 90 days, ordered by fact date. Marketing approvals, supplements, notices and review changes are labelled separately.
This source was last successfully updated at 2026/11/04 18:32; current coverage may be incomplete.
-
2026/08/24Accepted
-
2026/08/20Accepted
山东鲁抗医药集团赛特有限责任公司;吉林四环制药有限公司
CYHS2602077
Fact date: 2026/08/20 · Site observation date: 2026/10/21
View source ↗ -
2026/08/10Accepted
How current is each source?
- CDE acceptances and review
- Last successful update: 2026/11/05 06:45
- Chemical-drug catalogue
- Last successful update: 2026/11/05 06:39
Distinct full holder names; manufacturers are used only where the holder is unstated. The catalogue covers only part of the chemical-drug market. Categories are counted as recorded, not as a complete market census.
- Full API register
- Last successful update: 2026/11/05 06:40
- NHSA drug codes
- Last successful update: 2026/11/05 06:45
The fully loaded edition was maintained to 2026-10-23. Publication lags maintenance: the verified 2026-10-16 edition was published on 10-28, a 12-day gap. This is not a fixed lag for every edition.
- NMPA drug delivery notices
- Last successful update: 2026/11/04 18:32 · Current coverage may be incomplete
First index-page publication dates: 2026-10-21 to 2026-11-05; 1 pages pending. Covers loaded notices only, not a complete historical approval database.
Filings are counted by acceptance number and filing companies by first applicant. Strengths may have separate applications. Drug names are normalized only for width and whitespace; distinct generic names, dosage forms and combinations remain separate. Unstated strengths are marked. Company counts from different sources must not be added together.
Fact dates are approval dates, acceptance dates or complete-snapshot observation dates, as applicable. Publication and site-observation dates are separate. Historical backfills are not current-period events. Exit records cover currently inactive applications with an identifiable complete snapshot, not a full review history.
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